Roll-over Study to Continue Treatment With the Investigational Drug Rogaratinib and to Further Test Its Safety

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-30

Study Completion Date

2021-02-16

Brief Summary

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The purpose of this study is to enable patients, who are currently receiving rogaratinib in a Bayer-sponsored clinical trial (incl. NCT01976741), to continue treatment after their respective study has been closed. Another aim is to learn if rogaratinib is safe and how it affects the body.

Rogaratinib is an investigational drug that may treat different types of cancer, incl. non-small-cell lung cancer, small-cell lung cancer, urothelial carcinoma, head, neck and breast cancer. The drug may stop the growth of cancer cells by targeting different cell proteins called fibroblast growth factor receptors (FGFR) that are needed for the survival of the cancer cells.

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Detailed Description

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The primary objectives of the study are the continuation of rogaratinib treatment (as monotherapy or combination therapy) for patients after closure of their feeder studies and the further assessment of the safety of the drug.

The secondary objective is to investigate the tolerability of rogaratinib.

Conditions

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Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cancer patients

Patients from completed Bayer clinical trials, who received rogaratinib as monotherapy or combination therapy for the treatment of cancer.

Group Type EXPERIMENTAL

Rogaratinib (BAY1163877)

Intervention Type DRUG

Participants will be treated with investigational drug following the treatment schedule and dosing instructions from the feeder-study protocol.

Combination drug

Intervention Type DRUG

Any other drug specified in the protocol of the completed Bayer clinical trials that is used in combination with rogaratinib. Not all patients receive combination therapy.

Interventions

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Rogaratinib (BAY1163877)

Participants will be treated with investigational drug following the treatment schedule and dosing instructions from the feeder-study protocol.

Intervention Type DRUG

Combination drug

Any other drug specified in the protocol of the completed Bayer clinical trials that is used in combination with rogaratinib. Not all patients receive combination therapy.

Intervention Type DRUG

Other Intervention Names

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FGFR 1-4 inhibitor

Eligibility Criteria

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Inclusion Criteria

* Participants enrolled in any Bayer-sponsored rogaratinib feeder study at the time of study closure, who are currently receiving rogaratinib (monotherapy or combination therapy) and are experiencing clinical benefit from treatment, determined by the treating physician.
* Participants who meet criteria to initiate a subsequent cycle of therapy, as determined by the guidelines of the feeder study protocol.
* Any ongoing adverse events that required temporary treatment interruption must be resolved to baseline grade or assessed as stable and not requiring further treatment interruption.
* Women of childbearing potential and men with reproductive potential must be willing to continue practicing acceptable methods of birth control during the study treatment and until 6 months after stopping study treatment.

Exclusion Criteria

* Ineligibility, for medical reasons, to start the next treatment cycle in the respective feeder study.
* Patients with a beta-human chorionic gonadotropin (hCG) test consistent with pregnancy.
* Participants are using one or more of the prohibited medications listed in the respective feeder study protocol
* Negative benefit / risk ratio as determined by the investigator
* Positive pregnancy test for on-treatment participants

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No